Women's HealthNCT06460818
Surgical Sample Collection- Sampling During Uterine Surgery
An observational study of Women's Health, run by PinkDx, Inc. at 3 sites in United States.
Trial summary
The goal of this clinical trial is to evaluate anatomical locations for sample collection for future decisions for diagnostic test development. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Women's Health
- How many people
- 234 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Feb 2024to 29 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing hysterectomy.
Who may be able to join
- Evidence of a personally signed and dated informed consent form (ICF) indicating that the participant has been informed of all pertinent aspects of the study.
- Willing and able to comply with scheduled visits, investigational plan, and other procedures.
- Females:
- Aged >45 for benign and pre-malignant cases
- Aged >18 with positive biopsies.
- Presence of uterus.
- Scheduled for hysterectomy.
Who cannot join
- Investigator site staff members directly involved in the conduct of the study and their family members or participants who are Pink Dx, Inc. employees or their family members.
- Other acute or chronic medical or psychiatric conditions that would increase the risk associated with study participation in the judgement of the investigator.
- Women who have undergone a hysterectomy.
- Inability or unwillingness to sign informed consent.
- Contraindication to surgery, including pregnancy.
- Women who have used a tampon within 7 days of surgery.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Houston Methodist
Houston, Texas, 77030
Columbia University
New York, New York, 10032
Mayo Clinic
Rochester, Minnesota, 55905
About this study
The goal of this clinical trial is to evaluate anatomical locations for sample collection for future decisions for diagnostic test development.
- Conditions
- Women's Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| benign | tissue collection from women with benign reproductive conditions | |
| malignant | tissue collection from women with suspected and malignant reproductive conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with optimal vaginal samples obtained during the collection process
Number of participants with optimal vaginal samples obtained during the collection process, including preferred anatomical location and yields and quality of samples.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start27 Feb 2024
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Women's HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- PinkDx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Mariani, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460818
- Sponsor's protocol ID
- PNK001
- Status last verified
- Nov 2024
- First submitted
- 4 Jun 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Sample Collection- Sampling During Uterine Surgery
- ClinicalTrials.gov ID
- NCT06460818
- Acronym / sponsor ID
- PNK001
- Conditions
- Women's Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- PinkDx, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate anatomical locations for sample collection for future decisions for diagnostic test development.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| benign | – | –tissue collection from women with benign reproductive conditions |
| malignant | – | –tissue collection from women with suspected and malignant reproductive conditions |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing hysterectomy.
Key inclusion criteria (7 listed)
- Evidence of a personally signed and dated informed consent form (ICF) indicating that the participant has been informed of all pertinent aspects of the study.
- Willing and able to comply with scheduled visits, investigational plan, and other procedures.
- Females:
- Presence of uterus.
- Scheduled for hysterectomy.
Key exclusion criteria (6 listed)
- Investigator site staff members directly involved in the conduct of the study and their family members or participants who are Pink Dx, Inc. employees or their family members.
- Other acute or chronic medical or psychiatric conditions that would increase the risk associated with study participation in the judgement of the investigator.
- Women who have undergone a hysterectomy.
- Inability or unwillingness to sign informed consent.
- Contraindication to surgery, including pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with optimal vaginal samples obtained during the collection process
Time frame: 9 months
Number of participants with optimal vaginal samples obtained during the collection process, including preferred anatomical location and yields and quality of samples.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Mariani, MD principal investigator
Mayo Clinic
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Women's Health, run by PinkDx, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with optimal vaginal samples obtained during the collection process (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.